This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Status: PublishedPublication date: 2021-11
Edition: 4Number of pages: 48
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
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